cGMP Viral Vector Production for AAV Gene Therapies
Reliable, scalable cGMP processes that support your gene therapy through clinical production.
What Sets Forge Apart
Dedicated to AAV
Dedicated to AAV
Our exclusive focus on AAV gives us deeper expertise, specialized solutions, and more reliable support throughout cGMP manufacturing.
Seamless cGMP Scale-Up
Innovative Platform for Seamless cGMP Scale-Up
Our FUEL™ AAV manufacturing platform uses commercially viable technologies and proven processes to enable faster, more efficient scale-up to cGMP manufacturing.
Robust Quality & Compliance
Robust Quality & Compliance
Meeting FDA, EMA, and ISO standards.
End-to-End cGMP Support
End-to-End cGMP Support
From upstream cell banking to final fill-finish of drug product.
State-Of-The-Art CGMP Facility
State-of-the-Art cGMP Facility
20 cGMP suites and bioreactor scales ranging from 50L to 5,000L for cGMP AAV production.
Technology Transfer Services
Seamless Technology Transfer Services
Expert tech transfer services rooted in AAV know-how, with in-house process expertise and scalable support to move your program from transfer to execution with confidence.
Why Choose Forge Biologics for cGMP Manufacturing?
Extensive Manufacturing Experience at cGMP Scale
We offer expertise and experience in AAV viral vector cGMP production across numerous serotypes, indications, and cGMP scales, as well as in-house cGMP-Pathway plasmid production to enable faster, more streamlined manufacturing timelines.
Purpose-built cGMP Facility
The Hearth is equipped with 20 cGMP cleanroom suites dedicated to AAV production, and scalable bioreactors ranging from 50L to 5000L for cGMP production. Our sitewide flywheel regulates the energy coming into the building to help maintain consistent speeds and prevent machine downtime, leading to better productivity.
Integrated Regulatory Support for Clinical Programs
Our regulatory support for cGMP programs includes a Letter of Authorization to cross-reference Forge’s Drug Master File (DMF), and a Module 3 guide detailing sponsor responsibilities vs. DMF content, assistance with written responses to agency requests for information, and Site Master File. Additional regulatory services support additional clinical program needs such as participation in meetings with health authorities and overall regulatory strategy consulting.
Not Ready for cGMP Manufacturing? Explore Blaze, Our Research-Grade Production
Our cGMP Viral Vector Production Capabilities
Forge’s cGMP production—ranging from 50 to 5,000L—is designed for scalability, efficiency, and repeatable manufacturing success. Backed by deep technical expertise, our team leverages single-use technologies and optimized closed-system processes to produce larger batches with high throughput and minimal variability.
High-Yield Production Processes
- Proprietary cell line optimized for cGMP production and advanced bioreactor systems.
- Repeatable and consistent yields at various scales .
Upstream & Downstream Manufacturing
- Upstream: Cell culture, transfection, and harvest.
- Downstream: Purification—including chromatography and filtration steps.
- Fill-finish: Isolator technologies enabling semi and fully automated processes.
- Quality Focus: A proactive approach to incorporate quality at every stage, from design to delivery, to prevent rejects and optimize processes.
Analytical Development & Quality Control
- Comprehensive testing covering everything from sterility and purity to potency ensures final product safety.
- Real-time data tracking for proactive adjustments and trending analysis.
Plan Your Path to Scalable AAV cGMP Production
Whether you need early-phase clinical manufacturing or support scaling to larger cGMP batch sizes, Forge is built to help your gene therapy program move forward with confidence. Our team brings deep AAV cGMP expertise to help you reduce risk, meet timelines, and stay aligned with regulatory expectations.
Frequently Asked Questions
What cGMP capabilities does Forge Biologics provide?
Forge provides AAV cGMP manufacturing at scales from 50L to 5,000L, with integrated capabilities spanning upstream and downstream processing, plasmid production, analytical testing, and fill-finish — all under one roof.
What sets Forge Biologics’ cGMP viral vector production apart?
Gene therapy developers need more than a manufacturer; they need a true partner. At Forge, we were founded by developers, for developers, with deep AAV manufacturing expertise and a commitment to solving the unique challenges of gene therapy development and cGMP manufacturing. Our exclusive focus in AAV, custom-designed facility with extensive cGMP capacity, and investment in manufacturing technology, set us apart.
Can Forge accommodate early-phase manufacturing?
Yes, Forge supports early-phase developers with Blaze, our research-scale production at 1-40L scale for discovery work like material generation for proof-of-concept studies or assessing vector manufacturability. Our molecular development team can also provide early-phase guidance such as GOI construct evaluation for manufacturability.
How do you maintain cGMP standards across multiple projects?
At Forge, we maintain rigorous cGMP standards through dedicated cGMP cleanroom suites, validated processes, real-time quality monitoring, and strict adherence to FDA and other regulatory agency guidelines.
Do you offer regulatory support alongside manufacturing?
Yes, our integrated regulatory support for cGMP programs includes a Letter of Authorization to cross-reference Forge’s Drug Master File (DMF), and a Module 3 guide detailing sponsor responsibilities vs. DMF content, assistance with written responses to agency requests for information, and Site Master File. In addition to these standard services, Forge’s Regulatory team can support with participation in meetings with health authorities and comprehensive strategy consulting.
How quickly can Forge deliver a cGMP batch?
Timelines for cGMP batch delivery are highly dependent on the specifics of your program, including vector design, process readiness, and scope of work. Connect with our Client Development team to discuss your program and receive a more detailed scope of work based on your program needs.